University of Virginia
Vice President’s Office for Research
Post Approval Monitoring Review Form
IRB-HSR #__________________________
Principal Investigator___________________________________________________________________
*Study Coordinator_____________________________________________________________________
Review Date__________________
Approval: (UVA IRB-HSR)
expedited
full committee
IRB of record (not UVA): ________________________________________
Funding: ________________________________________
Is this a multi-center trial?  yes  no
Total number of subjects consented?_______________________
Is the study conducted under an IND or IDE?  Yes  No
(if applicable)
#____________________________________________________________________________________
_____________________________________________________________________________________
Is IND held by UVA MD (name if applicable)?  Yes  No
_____________________________________________________________________________________
Does the study enroll minors?
 Yes  No
If yes, are 2 parent signatures required?
Is the study approved for surrogate consent?
 Yes  No
 Yes  No
Is the study approved to enroll non-English speaking subjects (i.e. English and Spanish
informed consent short forms)?  Yes  No All should be YES: Comment on all NOs.
Review Item
YES
NO
N/A
Comments
Is the consent form consistent with the
protocol?
Are there systems in place to protect subject
confidentiality?
Is the number of subjects signing consent
less than the number approved by the IRBHSR (or IRB of record)?
Are there consents present for all subjects
enrolled?
Is there a subject log (all who have signed
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consent) available?
Are all copies (most recent and any
previous versions) of the protocol on file or
electronically available?
Is all correspondence (investigator
agreement/initial IRB approval letter,
approvals, modifications, continuations and
stamped consents) to and from the IRBHSR (or IRB of record) on file?
Is there a delegation of duties form and
training certificate if applicable?
Review Item
If specimens are processed in an
investigator lab, has IBC approval been
obtained? Is this question answered
correctly in the HSR database?
Is Radiation Safety Committee approval
required? If yes, are these approvals and
correspondence on file?
If advertising, are approvals on file and
does the advertising match the study?
Are all SAE reports submitted to the IRBHSR on file?
Was there any lapsed periods between IRB
approvals? If yes, were any subjects
enrolled during this lapsed period?
Decoding procedure for blinded studies?
YES
NO
N/A
Comments
Drug (Device if applicable) Inventory-if applicable
Where is the drug maintained?____________________________________________
Review Item
YES
NO N/A
Comments
Is the drug stored securely and with limited
access?
If drug maintained by UVA Investigational
Pharmacy, were DARF records reviewed?
Are shipping/receiving records available?
Is study drug accountability form
completed?
Study drug is not expired?
Are return shipping forms available?
Is the drug dispensed for each patient per
approved protocol?
Are the following details regarding drug
dispensation and return documented?
 Subject name (to whom dispensed)

Date drug dispensed
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
Amount of drug dispensed

Date remaining study drug returned

Name of person giving drug and
completing documentation (i.e.
tracking via paper drug log,
electronic IVRS system)
Study Monitoring:
Review Item
Is the DSMP appropriate for the study (r/t
level of risk, duration and details of subject
participation, etc)?
Was the plan followed as outlined per
approved protocol?
Has the safety monitoring taken place
according to the frequency dictated in the
DSMP?
Oncology studies: have AEs and SAEs been
entered in OnCore database as required?
If applicable, have DSMB reports been
submitted to IRB as required?
YES
NO
N/A
Comments
Comments: ___________________________________________________________________________
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_____________________________________________________________________________________
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Reviewer: _______________________
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SOP1-3A FORM Post Approval Monitoring Review
Date:______________________
6/30/15